NeoplasmsMRevaluationNCT01234701
Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI)
An observational study of Neoplasms, run by University of Zurich at 10 sites in 6 countries.
Trial summary
The purpose of this multicenter study is to evaluate the agreement among expert radiologists in interpreting magnetic resonance images (MRI) assessing common primary liver tumours in non-cirrhotic patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- Non-invasive Magnetic Resonance Imaging (MRI), Liver resection and Histopathology diagnosis of resected liver specimen
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Oct 2010to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinics
Who may be able to join
- Histopathological diagnosis of Hepatocellular Cancer (HCC), Adenoma and/or Focular nodular hyperplasia (FNH).
- Patients that received a pre-operative Magnetic Resonance Imaging (MRI).
- Patients that underwent liver resection with an intention to cure.
- Patient over 18 years of age
Who cannot join
- Other histopathological diagnosis such as cysts and hemangiomas.
- Patient age less than 18 years of age.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
United Kingdom3 sites
The Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
University College London Hospitals NHS Foundation Trust
London, NW1 2PG
Imperial College, Hammersmith Hospital
London, W12 0HS
United States2 sites
Harvard Medical School, Massachusetts General Hospital, and Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02117-0825
St. Louis University, Liver Center
St Louis, Missouri, 63110-0250
Switzerland2 sites
University Hospital Zurich, Department of Interventional and Diagnostic Radiology
Zurich, Canton of Zurich, 8091
University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
Zurich, Canton of Zurich, 8091
About this study
Official title: Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI) in Non-Cirrhotic Patients - A Double Blind International Multicenter Study
The purpose of this multicenter study is to evaluate the agreement among expert radiologists in interpreting magnetic resonance images (MRI) assessing common primary liver tumours in non-cirrhotic patients.
Read the detailed description
Magnetic Resonance Imaging (MRI) is currently the method of choice for non-invasive diagnosis of primary liver tumors. However, differentiation of hepatocellular carcinoma (HCC) from adenoma and focal nodular hyperplasia (FNH) remains challenging, particularly in non-cirrhotic patients.
- Conditions
- Neoplasms
- Being tested
- Non-invasive Magnetic Resonance Imaging (MRI), Liver resection, Histopathology diagnosis of resected liver specimen
- Keywords
- Liver, Neoplasms, Magnetic Resonance Imaging, Surgery, Pathology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Magnetic Resonance Imaging (MRI)Other
Also called Magnetic Resonance Imaging
Conventional pre-operative MRI
Liver resectionProcedure or surgery
Also called Hepatectomy = liver resection by open surgery.
Hepatectomy with an intention to cure
Histopathology diagnosis of resected liver specimenOther
Also called Examination under the microscope.
Histopathology diagnosis by expert pathologist.
| Study group | Role | What they receive |
|---|---|---|
| Primary liver tumors, non-cirrhotic | This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonance Imaging (MRI) and underwent resection for primary liver tumors. Receives: Other: Non-invasive Magnetic Resonance Imaging (MRI); Procedure: Liver resection; Other: Histopathology diagnosis of resected liver specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-observer agreement among expert radiologists in diagnosing primary liver tumors by Magnetic Resonance Imaging (MRI).
Inter-observer agreement for categorical data will by assessed by the Fliess' kappa (good agreement >0.7).
Measured: December 2010
Secondary outcomes (4)
Agreement of radiologists with the actual diagnosis of primary liver tumors assessed by Magnetic Resonance Imaging (MRI).
The actual diagnosis is defined as the histopathology diagnosis of the resected liver specimen, the current gold standard technique. Such agreement will be assessed by Cohen's Kappa (good agreement >0.7).
Measured: December 2010
Differences in radiologist' certainty of diagnosis (CoD) among different tumor types.
Radiologist' certainty of diagnosis (CoD) will be assessed by a Visual Analogue Scale (VAS 1-10). Potential differences in CoD will be identified by non-parametric multiple comparisons.
Measured: December 2010
Intra-class correlation coefficient among radiologists' Certainty of Diagnosis (CoD) in diagnosis primary liver tumors by Magnetic Resonant Imaging (MRI)
Intra-class correlation coefficient is a descriptive statistic that can be used when quantitative measurements are made on units that are organized into groups. It describes how strongly units in the same group resemble each other.
Measured: December 2010
Investigate the diagnostic efficacy of radiologists' certainty of diagnosis (CoD) in accurately predicting primary liver tumors assessed by Magnetic Resonant Imaging (MRI)
Diagnostic efficacy will be assessed by Receiver Operating Characteristic (ROC) Curves.
Measured: December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, University Hospital, Essen, Auckland City Hospital, University Hospital, Strasbourg, France, The Leeds Teaching Hospitals NHS Trust, Imperial College London, University College London Hospitals, St. Louis University
- Responsible party
- Sponsor
- Investigators
- Stefan Breitenstein, MD, Principal investigator, University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234701
- Sponsor's protocol ID
- MRI_Liver_Tumours_Evlauation
- Acronym
- MRevaluation
- Status last verified
- May 2012
- First submitted
- 3 Nov 2010
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI) in Non-Cirrhotic Patients - A Double Blind International Multicenter Study
- ClinicalTrials.gov ID
- NCT01234701
- Acronym / sponsor ID
- MRevaluation / MRI_Liver_Tumours_Evlauation
- Conditions
- Neoplasms
- Keywords
- Liver, Neoplasms, Magnetic Resonance Imaging, Surgery, Pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Harvard University, University Hospital, Essen, Auckland City Hospital, University Hospital, Strasbourg, France, The Leeds Teaching Hospitals NHS Trust, Imperial College London, University College London Hospitals, St. Louis University
- Study start
- Oct 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this multicenter study is to evaluate the agreement among expert radiologists in interpreting magnetic resonance images (MRI) assessing common primary liver tumours in non-cirrhotic patients.
Detailed description
Magnetic Resonance Imaging (MRI) is currently the method of choice for non-invasive diagnosis of primary liver tumors. However, differentiation of hepatocellular carcinoma (HCC) from adenoma and focal nodular hyperplasia (FNH) remains challenging, particularly in non-cirrhotic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary liver tumors, non-cirrhotic | – | Other: Non-invasive Magnetic Resonance Imaging (MRI), Procedure: Liver resection, Other: Histopathology diagnosis of resected liver specimenThis single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonance Imaging (MRI) and underwent resection for primary liver tumors. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinics
Key inclusion criteria (4 listed)
- Histopathological diagnosis of Hepatocellular Cancer (HCC), Adenoma and/or Focular nodular hyperplasia (FNH).
- Patients that received a pre-operative Magnetic Resonance Imaging (MRI).
- Patients that underwent liver resection with an intention to cure.
- Patient over 18 years of age
Key exclusion criteria (2 listed)
- Other histopathological diagnosis such as cysts and hemangiomas.
- Patient age less than 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive Magnetic Resonance Imaging (MRI)Also: Magnetic Resonance ImagingConventional pre-operative MRI | Other | Primary liver tumors, non-cirrhotic |
| Liver resectionAlso: Hepatectomy = liver resection by open surgery.Hepatectomy with an intention to cure | Procedure or surgery | Primary liver tumors, non-cirrhotic |
| Histopathology diagnosis of resected liver specimenAlso: Examination under the microscope.Histopathology diagnosis by expert pathologist. | Other | Primary liver tumors, non-cirrhotic |
Primary outcome
Inter-observer agreement among expert radiologists in diagnosing primary liver tumors by Magnetic Resonance Imaging (MRI).
Time frame: December 2010
Inter-observer agreement for categorical data will by assessed by the Fliess' kappa (good agreement >0.7).
4 secondary outcomes
Agreement of radiologists with the actual diagnosis of primary liver tumors assessed by Magnetic Resonance Imaging (MRI).
Time frame: December 2010
Differences in radiologist' certainty of diagnosis (CoD) among different tumor types.
Time frame: December 2010
Intra-class correlation coefficient among radiologists' Certainty of Diagnosis (CoD) in diagnosis primary liver tumors by Magnetic Resonant Imaging (MRI)
Time frame: December 2010
Investigate the diagnostic efficacy of radiologists' certainty of diagnosis (CoD) in accurately predicting primary liver tumors assessed by Magnetic Resonant Imaging (MRI)
Time frame: December 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
- Inter-rater reliability (also called: inter-rater agreement, or concordance) definitions and further informationLink provided by the sponsor.
- Fleiss' kappa informationLink provided by the sponsor.
- Cohen's kappa informationLink provided by the sponsor.
- Intraclass correlation informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Breitenstein, MD principal investigator
University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by University of Zurich at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, United States, Switzerland, France, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-observer agreement among expert radiologists in diagnosing primary liver tumors by Magnetic Resonance Imaging (MRI). (time frame: December 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2012.